A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A

January 4, 2024 updated by: Zhaohui Tong, Capital Medical University

This study is a prospective, multicenter, randomized controlled trial and aims to evaluate efficacy and safety of Xuanfei Baidu Granule in the treatment of influenza A.

This study plans to enroll 584 subjects. The subjects will be randomly divided into 4 groups according to the ratio of 1:1:1:1, and they will be treated with Xuanfei Baidu Granule Placebo, Xuanfei Baidu Granule, Xuanfei Baidu Granule combined with Baloxavir Marboxil tablet.1 bag of Xuanfei Baidu Granule and Xuanfei Baidu Granule Placebo in the morning and evening, and take with boiling water for 5 days. Baloxavir Marboxil Tablet was taken orally 2 tablets, once a day for 1 day.

The subjects were visited every day for 7 days after enrollment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
584

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Chaoyang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals aged ≥18 and <65, regardless of gender.
  • Meet the western medicine diagnostic criteria for influenza in the "2020 Edition of the Diagnosis and Treatment Scheme for Influenza".
  • Onset of illness within ≤72 hour.
  • Body temperature ≥37.5℃ within 24 hours before treatment.
  • Tested positive for influenza A virus by antigen.
  • The subject understands and voluntarily signs the informed consent, and is able to follow the visit and related procedures prescribed by the program.

Exclusion Criteria:

  • Individuals with known allergies to the test drugs, placebo components, or having allergic constitution.
  • Meet the criteria for severe or critical cases as per the "2020 Edition of the Diagnosis and Treatment Scheme for Influenza".
  • Patients with acute bacterial sinusitis, allergic rhinitis, tracheitis-bronchitis, pneumonia, herpetic pharyngitis, or similar diseases.
  • Individuals with severe primary diseases in cardiovascular, pulmonary, hepatic, renal, and hematopoietic systems.
  • Patients with mental illness or those unable or unwilling to cooperate.
  • History of epilepsy or febrile convulsions.
  • Obesity (BMI >30).
  • Patients with acute and chronic gastroenteritis and unexplained diarrhea within 1 week before administration.
  • Liver function test values (ALT, AST) exceed 60U/L;Serum creatinine over 106μmol/L.
  • Use of other drugs for the treatment of the disease within 24 hours before administration (including antiviral, hormone and other Chinese and Western drugs and treatment methods).
  • Suspected or confirmed history of alcohol or drug abuse, heavy smoker.
  • Women who are pregnant or trying to become pregnant, breastfeeding women, those of childbearing age who are unable or unwilling to use adequate contraception during the trial or whose spouse is unwilling to use contraception.
  • Immunodeficient, immunosuppressed patients or those who have received steroid therapy or other immunosuppressive therapy in the last 3 months.
  • Received influenza vaccine within the last 12 months.
  • Participants who have participated in other interventional clinical trials within the last 3 months.
  • Participants considered unsuitable for this clinical trial by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Xuanfei Baidu Granule Placebo group
Drug: Xuanfei Baidu Granule Placebo
Take Xuanfei Baidu Granule Placebo 1 bag in the morning and evening with boiling water for 5 days.
Experimental: Xuanfei Baidu Granule group
Drug: Xuanfei Baidu Granule
Take Xuanfei Baidu Granule 1 bag in the morning and evening with boiling water for 5 days.
Active Comparator: Baloxavir Marboxil Tablet group
Drug: Baloxavir Marboxil Tablet
Take Baloxavir Marboxil Tablet 2 tablets orally, once a day, for 1 day.
Active Comparator: Combination group
Drug: Xuanfei Baidu Granule
Take Xuanfei Baidu Granule 1 bag in the morning and evening with boiling water for 5 days.
Drug: Baloxavir Marboxil Tablet
Take Baloxavir Marboxil Tablet 2 tablets orally, once a day, for 1 day.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The time to fever resolution.
Time Frame: within 7 days of enrollment

Definition of fever resolution: the body temperature drops to ≤37 ℃ and is maintained for more than 24 hours.

Definition of time to fever resolution: the time from the first dose to the resolution of fever.
within 7 days of enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The time to alleviation of influenza symptoms.
Time Frame: within 7 days of enrollment

Influenza symptoms include cough, sore throat, headache, stuffy nose, chills/sweating (feeling hot), muscle aches and fatigue.

Influenza symptoms was measured by Influenza Symptom Rating Scale.The minimum and maximum value of every symptom is 0 and 3, respectively. Higher score means a worse outcome.

Definition of alleviation of influenza symptoms: symptom score ≤1. Definition of time to alleviation of influenza symptoms: the time from the first dose to symptom improvement.
within 7 days of enrollment
The proportion of patients with fever resolution.
Time Frame: within 7 days of enrollment
Definition of fever resolution: the body temperature drops to ≤37 ℃ and is maintained for more than 24 hours.
within 7 days of enrollment
The proportion of patients with alleviation of influenza symptoms.
Time Frame: within 7 days of enrollment

Influenza symptoms include cough, sore throat, headache, stuffy nose, chills/sweating (feeling hot), muscle aches and fatigue.

Influenza symptoms was measured by Influenza Symptom Rating Scale.The minimum and maximum value of every symptom is 0 and 3, respectively. Higher score means a worse outcome.

Definition of alleviation of influenza symptoms: symptom score ≤1.
within 7 days of enrollment
The proportion of patients with alleviation of clinical symptoms.
Time Frame: within 7 days of enrollment

Clinical symptoms include fever resolution and alleviation of influenza symptoms.

Influenza symptoms include cough, sore throat, headache, stuffy nose, chills/sweating (feeling hot), muscle aches and fatigue.

Influenza symptoms was measured by Influenza Symptom Rating Scale.The minimum and maximum value of every symptom is 0 and 3, respectively. Higher score means a worse outcome.

Definition of fever resolution: the body temperature drops to ≤37 ℃ and is maintained for more than 24 hours.

Definition of alleviation of influenza symptoms: symptom score ≤1.
within 7 days of enrollment
The temporal variation of body temperature.
Time Frame: within 7 days of enrollment
The temperature was measured at 8 o 'clock, 12 o 'clock, 16 o 'clock and 20 o 'clock every day, and the measurement time and measurement results were recorded.
within 7 days of enrollment
The temporal variation of Influenza Symptom Rating Scale.
Time Frame: within 7 days of enrollment

Influenza symptoms include cough, sore throat, headache, stuffy nose, chills/sweating (feeling hot), muscle aches and fatigue.

Influenza symptoms was measured by Influenza Symptom Rating Scale.The minimum and maximum value of every symptom is 0 and 3, respectively. Higher score means a worse outcome.
within 7 days of enrollment
All-cause hospitalization rate.
Time Frame: within 7 days of enrollment
All-cause hospitalization rate.
within 7 days of enrollment
The incidence of clinical abnormalities was examined in the laboratory.
Time Frame: within 7 days of enrollment
The incidence of clinical abnormalities was examined in the laboratory.
within 7 days of enrollment
The incidence of clinical abnormalities was examined by electrocardiogram.
Time Frame: within 7 days of enrollment
The incidence of clinical abnormalities was examined by electrocardiogram.
within 7 days of enrollment
The incidence of all-cause adverse events during the study period.
Time Frame: within 7 days of enrollment
The incidence of all-cause adverse events during the study period.
within 7 days of enrollment
The incidence of serious adverse events during the study period.
Time Frame: within 7 days of enrollment
The incidence of serious adverse events during the study period.
within 7 days of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XFBD-JL-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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